23价肺炎球菌多糖疫苗上市后在湖北省大规模使用的安全性评价

Safety evaluation of 23-valent pneumococcal polysaccharide vaccine’s large-scale use in Hubei after listing

目的评价23价肺炎球菌多糖疫苗(PPV23)的安全性,为肺炎防治中相关免疫接种策略提供科学依据。方法通过主动监测和被动监测收集接种PPV23后的疑似预防接种异常反应(AEFI),两组间不良反应发生率和反应类型的比较等进行χ~2检验和方差分析,P<0.05(双侧)为差异有统计学意义。结果截至2018年3月31日,被动监测共122 368人,累计报告AEFI 188例,发生率为153.64/10万。其中一般反应180例,发生率为147.09/10万,以发热和轻微红肿为主;异常反应8例,发生率为6.54/10万,均为过敏性皮疹。主动监测共2 194人,累计报告AEFI 191例,发生率为8 705.56/10万,均为一般反应,以发热和轻微红肿为主,无异常反应。主动监测组的不良反应发生率明显高于被动监测组,差异有统计学意义(χ~2=5 196.567,P<0.05)。两组在不同年龄组的AEFI发生情况不同,被动监测组AEFI发生以7~17岁年龄段居多,主动监测组以2~6岁年龄段居多,差异有统计学意义(χ~2=53.163,P<0.05)。主动监测结果显示PPV23接种后30min^24h体温明显上升,48h后显著下降,体温变化差异有统计学意义(F=22.880,P<0.05)。结论由玉溪沃森生物技术有限公司生产的PPV23具有良好的安全性,接种后需在24h内对2~17岁儿童重点关注。

Objective To evaluate the safety of 23-valent pneumococcal polysaccharide vaccine(PPV23),provide data support for vaccination strategies related to prevention and treatment of pneumonia.Methods Adverse Events Following Immunization(AEFI)after PPV23 vaccination was collected through active and passive surveillance.Chi-square test and variance analysis were used to compare the incidence and types of adverse reactions between the two groups.P<0.05(bilateral)was statistically significant.Results By the end of March 31,2018,there were 122 368 cases of passive surveillance,188 AEFI cases were reported,and the incidence of AEFI was 153.64/100 000.There were 180 general reaction(147.09/100 000)include mainly fever and mild redness,8 cases of paradoxical reaction(6.54/100 000)were all allergic rash.Two thousand one hundred and ninety-four cases were monitored actively,191 AEFI cases(8 705.56/100 000)were all general reactions,mainly fever and mild redness were included,and no abnormal reactions were found.The incidence of adverse reactions in the active monitoring group was significantly higher than that in the passive monitoring group,the difference was significant(χ~2=5 196.567,P<0.05).The incidence of AEFI was different between the two groups in different age groups,the difference was significant(χ~2=53.163,P<0.05).AEFI occurred mostly in 7-17 years in passive surveillance group while in 2-6 years in active surveillance groups.Active surveillance results showed that the body temperature increased significantly from 30 min to 24 h,and decreased significantly after 48 h,the change of body temperature had statistical significance(F=22.880,P<0.05)r.Conclusion PPV23 produced by Yuxi Watson Biotechnology Co.,Ltd.has good safety.It should be focused on children aged 2 to 17 within 24 hours after inoculation.